Treating PCOS With Digital Intervention vs. Metformin

Polycystic Ovary Syndrome Clinical Trial

Official title:

Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386706
• Other study ID #: Digital Intervention PCOS
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

Description:

This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2023
• Est. primary completion date: August 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance

Exclusion Criteria:

Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (= 3 times the upper limit of the normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Behavioral:
• Digital Intervention
This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Drug:
• Metformin
Traditional metformin monotherapy.

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis model assessment of insulin resistance	insulin resistance index	3 months
Secondary	Anthropometry	body mass index (kg/m2)	3 months
Secondary	menstrual frequency	number of menstruation in a year	3 months
Secondary	fasting glucose	fasting glucose(mmol/L)	3 months
Secondary	fasting insulin	fasting insulin(mmol/L)	3 months
Secondary	Total cholesterol	Total cholesterol (mmol/L)	3 months
Secondary	Triglycerides	Triglycerides (mmol/L)	3 months
Secondary	HDL-c	HDL-c (mmol/L)	3 months
Secondary	LDL-c	LDL-c (mmol/L)	3 months
Secondary	total testosterone	total testosterone (nmol/L)	3 months
Secondary	free testosterone	free testosterone (nmol/L)	3 months
Secondary	Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	3 months
Secondary	Androstenedione	Androstenedione (ng/ml)	3 months
Secondary	Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	3 months
Secondary	International Physical Activity Questionnaire (IPAQ)	Assess physical activity situation in women with PCOS.	3 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Assess sleep situation in women with PCOS.	3 months
Secondary	Hospital Anxiety and Depression Scale (HADS)	To evaluate anxiety and depression in PCOS women.	3 months
Secondary	Three-Factor Eating Questionnaire (TFEQ-R21)	Assess eating behavior in women with PCOS.	3 months